BLOC-ICH: Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage (BLOC-ICH)
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|ClinicalTrials.gov Identifier: NCT03737344|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2018
Last Update Posted : March 4, 2021
This trial will help inform the development of a new treatment for intracerebral haemorrhage (ICH; also known as haemorrhagic stroke). ICH is a type of stroke caused by spontaneous bleeding into the brain. In the hours to days after bleeding occurs, inflammation develops in the brain around the haematoma (collection of blood in the brain). Inflammation is the body's natural response to injury, however when it continues unchecked there is a risk that the brain tissue around the haematoma will become swollen. This type of swelling can worsen existing stroke symptoms or cause new deficits such as speech disturbance and limb weakness, which can lead to long term disability.
The level of inflammation in the blood is high after ICH. The investigators want to investigate whether blocking this inflammation can improve overall recovery. The investigators research group has extensively investigated the use of a well-established anti-inflammatory drug, Kineret® in trials with patients who have suffered a stroke or brain haemorrhage. Kineret® is similar to a naturally-produced protein called interleukin-1 receptor antagonist (IL-1Ra) and is already licensed to treat patients with rheumatoid arthritis. The investigators have evidence from these previous studies that Kineret® reduced levels of inflammation in the blood after ischaemic stroke (caused by a blockage in an artery). However, in order to develop Kineret® as a treatment for ICH, the investigators need to know if it reduces levels of inflammation present in the blood following ICH and if it reduces swelling in the brain.
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Haemorrhage||Drug: IL-1Ra Kineret® Other: IL-1Ra Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase II Trial of Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage: BLOcking the Cytokine IL-1 in ICH|
|Actual Study Start Date :||May 17, 2019|
|Actual Primary Completion Date :||February 19, 2021|
|Estimated Study Completion Date :||May 1, 2021|
Active Comparator: IL-1Ra Kineret®
100mg doses of the trial drug Kineret® will be administered subcutaneously (SC) twice daily (12 hourly) starting within 8 hours of symptoms onset for a maximum of 3 days from symptoms onset (or sooner if discharged from neurosurgical centre).
Drug: IL-1Ra Kineret®
Kineret® 100 mg in 0.67 ml Prefilled Syringe
Other Name: Anakinra
Placebo Comparator: IL-1Ra Placebo
100mg doses of the placebo will be administered subcutaneously (SC) twice daily (12 hourly) starting within 8 hours of symptoms onset for a maximum of 3 days from symptoms onset (or sooner if discharged from neurosurgical centre).
Other: IL-1Ra Placebo
Placebo identical to Kineret® 100 mg in 0.67 ml Prefilled Syringe
- Oedema extension distance (OED) [ Time Frame: 72 hours (+/-12 hours) post symptoms onset ]Perihaematomal OED on CT scan at 72 hours (+/-12 hours), which equates to the average distance that oedema extends beyond the haematoma border.
- Early haematoma growth [ Time Frame: between baseline and 72 hours post symptoms onset ]Early haematoma growth (defined as ≥33% or ≥6 ml increase in haematoma volume between baseline and 72 hours)
- Early Neurological Decline (END) [ Time Frame: between baseline and 72 hours post symptoms onset ]The average decrease of ≥2 in the Glasgow Coma Scale (GCS) score or an increase in the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4, lasting longer than 8 h, requiring surgical intervention, or resulting in death.
- Inflammatory markers [ Time Frame: from day 0 (baseline) to day 4 post randomisation ]Area under the curve for inflammatory markers of C-reactive protein (CRP) versus Interleukin-6 (IL-6)
- Quantitative blood-brain barrier permeability [ Time Frame: day 2-4 post randomisation ]Measure of the blood-brain barrier permeability in the perihaematomal brain using a tracer kinetic model, which generates maps of the blood-brain transfer constant K^trans
- modified Rankin Score (mRS) [ Time Frame: 3 months post randomisation ]Measure of ordinal shift in degree of disability or dependence in daily activities
- Stroke Impact Scale (SIS) [ Time Frame: 3 months post randomisation ]stroke-specific quality of life measure
- Fatigue severity score (FSS) [ Time Frame: 3 months post randomisation ]Severity of fatigue and it's effect on the participant's activities and lifestyle
- EQ-5D-5L [ Time Frame: 3 months post randomisation ]health-related quality of life measure
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 months post randomisation ]Measurement of mood
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737344
|Salford Royal NHS Foundation Trust|
|Manchester, North West, United Kingdom, M6 8HD|
|Principal Investigator:||Adrian Parry-Jones, PhD, MRCP||University of Manchester|